Clinical trial · Interventional
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT04129320CI-TRIAL-00056384withdrawnPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in study design
Summary
Brief summary (as posted)
This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enoblituzumab | Biological | — | UNRESOLVED |
| MGA012 | Biological | Retifanlimab | ALIAS |
| MGD013 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm 1
- description
- Enoblituzumab plus MGA012
- interventionNames
- Biological: enoblituzumab
- Biological: MGA012
- type
- EXPERIMENTAL
- label
- Experimental Arm 2
- description
- Enoblituzumab plus MGD013
- interventionNames
- Biological: enoblituzumab
- Biological: MGD013
Primary outcomes (2)
- measure
- Overall Response Rate (Modules X and Y)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven, recurrent or metastatic SCCHN not curable by local therapy * No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed \> 6 months prior of given as part of multimodal treatment for locally advanced disease) * Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx * At least one radiographically measurable lesion * HPV test results available (positive and negative eligible) * ECOG Performance status of 0 or 1 * Adequate end organ function * Positive PD-L1 expression level (CPS ≥ 1%) Exclusion Criteria: * Disease suitable for local therapy administered with curative intent * Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN * Radiation or other non-systemic therapy within 2 weeks of first dose of study drug * Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug
References
Publications (0)
Data not yet available
No reference posted for this study.